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New treatment option for Biliary Tract Cancers (BTC)
Official title Cosiporfin Sodium for Injection Photodynamic Therapy
ClinicalTrials.gov ID: NCT07398339
What this study is testing
What is Cosiporfin Sodium for injection, DVDMS?
Cosiporfin Sodium for injection, DVDMS is an investigational medicine, being studied as a potential treatment for biliary tract cancers (btc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study Design: Multicenter, open-label, Single Group Study Population: Patients with locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery. Primary Research Objective: To preliminarily evaluate the efficacy of photodynamic therapy (PDT) with sodium protoporphyrin combined with gemcitabine and cisplatin (GC regimen) chemotherapy in patients with advanced extrahepatic cholangiocarcinoma complicated by biliary obstruction.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must meet all of the following to be enrolled in this study:
- All people or their legal representatives must voluntarily sign an ethics committee-approved informed consent form in writing prior to initiating any...
- Age ≥ 18 years, no gender restrictions;
- Patients with histologically or cytologically confirmed, locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable...
- No prior systemic therapy during the recurrent or metastatic stage;
You likely can't join if
- people meeting any of the following criteria are ineligible for enrollment:
- Patients with ampullary cancer;
- Known hypersensitivity to sodium porphyrin or other photosensitizing agents;
- Diffuse liver metastases or liver tumor burden exceeding 50% of liver volume;
- Known or suspected brain metastases, leptomeningeal metastases, or spinal cord compression (including asymptomatic cases and those adequately...
- people who participated in any other drug clinical trial or other treatment clinical trial within 4 weeks prior to study drug administration, except...
See the full eligibility criteria
Who can join
- people must meet all of the following to be enrolled in this study:
- All people or their legal representatives must voluntarily sign an ethics committee-approved informed consent form in writing prior to initiating any screening procedures;
- Age ≥ 18 years, no gender restrictions;
- Patients with histologically or cytologically confirmed, locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery;
- No prior systemic therapy during the recurrent or metastatic stage;
- Presence of obstructive lesions in the extrahepatic bile ducts, with at least one measurable lesion outside the bile ducts according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
- people with an ECOG performance status score of 0 or 1 (see Appendix 3 for details);
- people with an expected survival of ≥3 months;
- people with adequate organ and bone marrow function meeting the following laboratory criteria:
- Bone marrow function: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (1500/mm³) ; platelets ≥100 × 10⁹/L (1 × 10⁵/mm³); hemoglobin ≥9.0 g/dL (no treatment for bone marrow suppression, such as GCS-F, EPO, or blood...
- Renal Function: Creatinine clearance (Ccr) ≥50 mL/min (calculated using the Cockcroft-Gault formula; see Appendix 4);
- Coagulation Function: International Normalized Ratio (INR) ≤1.5 × ULN; Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN;
- Echocardiogram: Left ventricular ejection fraction (LVEF) ≥50%;
- 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \<470 msec (Appendix 4);
- Recovered from all prior treatments with toxicities resolved to Grade 1 or below;
- Female people of childbearing potential and all male people must agree to use highly effective contraception during the trial and for 6 months after the last dose of sodium porphyrin. contraceptive gel, contraceptive...
What rules you out
- people meeting any of the following criteria are ineligible for enrollment:
- Patients with ampullary cancer;
- Known hypersensitivity to sodium porphyrin or other photosensitizing agents;
- Diffuse liver metastases or liver tumor burden exceeding 50% of liver volume;
- Known or suspected brain metastases, leptomeningeal metastases, or spinal cord compression (including asymptomatic cases and those adequately treated);
- people who participated in any other drug clinical trial or other treatment clinical trial within 4 weeks prior to study drug administration, except for people participating in observational (non-treatment) clinical...
- Previous exposure to photosensitizers or photodynamic therapy;
- Patients with unremovable stents in the extrahepatic bile ducts;
- Patients with prior history of immunotherapy (including but not limited to various anti-PD-1 monoclonal antibodies, anti-PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies, etc.), gemcitabine, or cisplatin...
- people who underwent major surgery within 4 weeks prior to study drug administration;
- people who used Chinese herbal medicines with immunomodulatory or antitumor effects within 14 days prior to study drug administration;
- people with advanced cholangiocarcinoma in a cachectic state or who are not expected to tolerate photodynamic therapy;
- Patients with Bismuth Type IV hilar cholangiocarcinoma;
- Individuals unsuitable for ERCP or endoscopic procedures;
- people requiring concomitant antitumor therapy during study drug treatment, including chemotherapy regimens other than GC, radiotherapy, immunotherapy, or biologic agents;
- Any other malignancy diagnosed within 5 years prior to the first study drug administration, except for any type of carcinoma in situ, micro- or low-risk papillary thyroid carcinoma, and cured basal cell carcinoma or...
- History of allogeneic organ transplantation, or known history of autologous or allogeneic hematopoietic stem cell transplantation;
- Presence of clinically significant (malignant/cancerous, or moderate to large volume) pleural effusion, ascites, or pericardial effusion within 4 weeks prior to the first dose of porphyrin sodium; however, people with...
- Presence of acute inflammation (especially necrotizing inflammation) or clinically significant active infection;
- Hepatitis C virus (HCV) RNA positive, active syphilis, or positive results for any one or more of the following: human immunodeficiency virus (HIV) antibody test, or active hepatitis B (defined as HBV DNA ≥ 2000 IU/mL...
- Clinically significant cardiovascular disease or conditions, including but not limited to:
- Myocardial infarction within 6 months prior to first dosing;
- Uncontrolled angina pectoris within 3 months prior to first dosing;
- History or current presence of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes) or other ≥ Grade 2 persistent arrhythmias (per NCI-CTCAE v5.0);
- History or current presence of congestive heart failure [New York Heart Association (NYHA) Class III or IV (Appendix 5)];
- Complete left bundle branch block or complete right bundle branch block with left anterior fascicular block (double bundle branch block);
- Long QT syndrome or confirmed family history of long QT syndrome; known concomitant use of QT-prolonging medications;
- Bradycardia, defined as a screening ECG showing a heart rate \< 45 beats per minute;
- Hypotension, defined as a screening systolic blood pressure ≤86 millimeters of mercury (mmHg);
- Uncontrolled hypertension, where the subject receives standard antihypertensive therapy but has a screening systolic blood pressure \> 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
- Cerebrovascular events (including hemorrhagic, ischemic, transient ischemic attacks), cranial surgery, or unexplained loss of consciousness within 6 months prior to the first dose;
- Severe pre-existing conditions such as interstitial lung disease, severe dyspnea occurring at rest or requiring supplemental oxygen, inability to lie flat due to acute asthma exacerbation or respiratory failure, active...
- Thromboembolic disease within 6 months prior to first dose;
- Uncontrolled psychiatric illness/social circumstances expected to limit compliance with study requirements or impair the subject's ability to provide written informed consent;
- Known history of psychiatric drug abuse or substance abuse;
- Pregnant or lactating women;
- Receipt of a live vaccine within 4 weeks prior to the first dose;
- Other reasons deemed by the investigator to make the subject unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Pudong New Area, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Pudong New Area, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.